drugset / Trial / NCT00823316
Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.
Timeline
- Start
- 2008-08
- Primary completion
- 2010-02
- Completion
- 2010-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human umbilical cord blood derived mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | human umbilical cord blood derived mesenchymal stem cells | Cell therapy | 5e+06 cells/kg | Intravenous |